Regulatory
Pfizer Trial Supports Paxlovid Dose for High-Risk Children Under 12
Key Facts
Signal Type
Regulatory
Industry
Biotech
Companies
Pfizer
Date
June 26, 2026
Pfizer's phase 2/3 trial of Paxlovid in children aged 6-17 showed robust SARS-CoV-2 RNA reduction and no COVID-related hospitalizations or deaths. The study, published in Pediatrics, provides pharmacokinetic data supporting potential EUA expansion for younger children.
Pediatric infectious disease specialists and hospital antimicrobial stewardship programs treating high-risk children (6-12 years) with conditions like chronic lung disease or diabetes. Boston Children's Hospital clinicians are already evaluating the data for clinical implications.
Pfizer's next regulatory move - whether they'll seek full FDA approval for 6+ year olds. Also monitor IDSA's upcoming pediatric COVID treatment guidelines, likely to reference this data.
Source:
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